Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

August 13, 2014 updated by: Probi AB
The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 405 30
        • Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age ≥19 and ≤45 years
  • Hb >117g/L

Exclusion Criteria:

  • Gastrointestinal diseases
  • Metabolic diseases
  • Use of other probiotic products during the study and 2 weeks before the study start
  • Pregnant or breast-feeding
  • A serum ferritin level >60 µg/L
  • Medication (oral contraceptives allowed)
  • Intake of dietary supplements (incl. iron) during the study and two weeks before the study start
  • No blood donation in the last 2 months
  • High C-reactive protein levels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: L plantarum DSM 9843 or placebo
Active Comparator: L plantarum DSM 9843
Dietary supplement: L plantarum DSM 9843 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron absorption ratio in blood samples
Time Frame: 14 days
Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ProIron

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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